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Library > Technical Papers

What Makes 505(b)(2) Different?

Camargo | 19-Mar-2013 | PDF Technical / white paper
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different anima...
Capsugel

Vcaps® Plus capsules: The next generation HPMC capsule for optimum formulation of Pharmaceutical Dosage forms

Capsugel | 28-Feb-2013 | PDF Research study
Traditionally, HPMC capsules have been formulated with secondary gelling agents and ionic gel promoters, which may lead to unwanted issue...

New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers

World Courier | 11-Feb-2013 | PDF Technical / white paper
World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel a...
Recipharm

VENDOR MANAGED INVENTORY

Recipharm AB | 11-Feb-2013 | PDF Case study
VENDOR MANAGED INVENTORYCONTINUED GROWTH IN DEMAND FOR VMI Vendor Managed Inventory (VMI) can be defined as a means of optimising su...

Identifying the Product

Camargo | 06-Feb-2013 | PDF Technical / white paper
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and low...

Quantify biodistribution, enhance in vivo decisions

Molecular Imaging Inc. | 04-Feb-2013 | PDF Data sheet
Non-invasive preclinical SPECT imaging of test agent biodistribution, kinetics and targeting in discovery and safety applications has key...

Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI

Almac Group | 21-Jan-2013 | PDF Case study
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac...

Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain

World Courier | 01-Jan-2013 | PDF Technical / white paper
WORLD COURIER is the market leader in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products...

Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing

SGS | 03-Dec-2012 | PDF Technical / white paper
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtai...

Analytical Method Development and Validation — A CDMO Perspective

DPT Labs | 28-Nov-2012 | PDF Insight guide
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical devel...
Smaller pharma companies financially benefitting from CDMO partnerships

Smaller pharma companies financially benefitting from CDMO partnerships

Recipharm AB | 26-Nov-2012 | PDF Case study
In today’s global economy, available financing is increasingly scarce for pharmaceutical companies looking to bring new products to marke...

INFLUENZA TREATMENT CLINICAL TRIALS: CLINICAL CASE STUDIES

SGS | 19-Nov-2012 | PDF Technical / white paper
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview...
Baxter

Lyophilized Pharmaceuticals: A Design Space Approach

Baxter | 29-Oct-2012 | PDF Technical / white paper
This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for...

Extractables & Leachables Risk Assessment

SGS | 22-Oct-2012 | PDF Case study
An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production proces...

Biosafety Testing: In Vitro Virus Detection

SGS | 09-Oct-2012 | PDF Technical / white paper
Regulatory authorities (US FDA and the EMEA) impose stringent limits on the amount of microbial contaminates and impurities present durin...

Identifying a Differentiated Product – 505(b)(2)

Camargo | 08-Oct-2012 | PDF Data sheet
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential a...

Vetter – Answers that work

Vetter Pharma International GmbH | 03-Oct-2012 | PDF Data sheet
There are many sides to your product’s success. Build them together at Vetter.Whether your injectable is still at the starting line or in...

Identifying the Product

Camargo | 26-Sep-2012 | PDF Technical / white paper
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential a...

Biomarkers of Toxicity Panel in Clinical Trials

ACM Global Central Laboratory | 18-Sep-2012 | PDF Technical / white paper
Most drug candidates are discontinued because of induced organ toxicity and half of them owe this to liver toxicity. This issue explains...

505(b)(2): Fast and Cost-Effective Drug Approval

Camargo | 10-Sep-2012 | PDF Data sheet
Looking to identify a new product for development or improve an existing compound? For lower risk, reduced cost and faster speed to marke...

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